System and method for the treatment of insomnia

ABSTRACT

A system and method that provides controlled bilateral stimulation to a patient in response to physiological feedback to initiate and/or accelerate the onset of sleep and to maintain the sleep state after the onset of sleep. The system induces bilateral stimulation through stimulation modules that are coupled to opposite lateral sides of the patient&#39;s body. The stimulation modules stimulate the patient&#39;s body bilaterally through a sequence of stimulations that alternate from one side of the patient&#39;s body to the other with a pause between each successive stimulation. The system controls the duration of the stimulations, the intensity of the stimulations and the period of time between successive stimulations in response to feedback from physiological sensors. The sensors are coupled to the patient and provide physiological information which initiates or terminates the bilateral stimulations, and/or modifies the characteristics of the stimulations.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/189,747, filed Feb. 25, 2014, which claims priority as acontinuation-in-part to PCT Application No. PCT/US12/52234, entitled“System and Method for The Treatment of Insomnia” filed on Aug. 24,2012, which claims priority to U.S. Provisional Application No.61/527,205 entitled “ System and Method for The Treatment of Insomnia”filed on Aug. 25, 2011, the entire contents of which are herebyincorporated by reference in their entireties.

TECHNICAL FIELD

The present invention relates to devices and methods used in thetreatment of insomnia, and more particularly to devices and methods thatinitiate and/or accelerate the onset of sleep and devices and methodsthat maintain sleep after onset of sleep, in response to physiologicalfeedback.

The present invention provides a novel, non-invasive medical device fortreating insomnia, by initiating and maintaining sleep employingbilateral stimulation in conjunction with physiological feedback.

BACKGROUND

Prior treatments for insomnia are primarily limited to behavioraltherapy, including Cognitive Behavioral Therapy for Insomnia (CBT-I) andto pharmacological therapy including over the counter medications.Behavioral therapies are lengthy processes, which depend upon thepatient's ability to maintain compliance with specific therapeuticactivities. Pharmacological therapies raise concerns over long-term use,physiological side effects, and addictive responses.

In general, insomnia presents in multiple manifestations, includinglatency of sleep onset and waking after sleep onset. Furthermore,insomnia may present as a primary condition or as a secondary conditionto other morbidities, including depression, anxiety and post-traumaticstress disorder.

The current practice for diagnosing sleep disorders includesadministering a Polysomnogram (PSG), which measures biophysiologicalactivity during sleep. The PSG employs Electroencephalography (EEG) tomeasure electrical activity within the brain. The EEG data are used todetermine the wakefulness of the patient.

Current practice for diagnosing sleep disorders also includesactigraphy, which uses actimetry sensors composed of accelerometers tomeasure gross motor activity to determine the wakefulness of thepatient.

A type of psychotherapy used in the treatment of trauma known as EyeMovement Desensitization and Reprocessing, EMDR, uses bilateralstimulation in conjunction with other psychotherapy mechanisms toachieve more rapid recovery from traumatic events than is normallyachieved without bilateral stimulation. It is believed that thebilateral stimulation produces shifts in regional brain activation andneuromodulation similar to those produced during REM sleep, and thatthis activation shifts the brain into a memory-processing mode similarto that of REM sleep, which permits the integration of traumaticmemories.

There are numerous approaches that have been employed to treat and/orameliorate the effects of insomnia and the ability to maintain a startedsleep. One such approach is common behavioral therapy for treatinginsomnia including stimulus control, such as not working, reading orwatching TV in bed, which attempts to eliminate the association of thebed with negative outcomes such as wakefulness and to create a positiveassociation between the bed and sleep.

Another common behavioral therapy for treating insomnia is relaxationtraining where activities such as guided imagery and muscle relaxationare used to reduce arousal states, which interfere with sleep.

Another common behavioral therapy for treating insomnia is sleeprestriction, which limits the amount of time spent in bed when notasleep, and prohibits sleeping during non-prescribed times, e.g.afternoon napping, in order to improve the continuity of sleep.

Another common behavioral therapy for treating insomnia is CognitiveBehavior Therapy for Insomnia (CBT-I), which combines cognitive behaviortherapy with other behavior therapies such as sleep restriction,stimulus control and relaxation training.

Another common behavioral therapy for treating insomnia is sleephygiene, which teaches patients about practices that improve sleep, suchas proper diet, exercise, avoiding stimulants, maintaining a quiet sleepenvironment and avoiding napping.

Another common behavioral therapy for treating insomnia is biofeedbacktherapy, which utilizes auditory or visual feedback to control somephysiological variable in order to reduce arousal states, whichinterfere with sleep.

Some patients with insomnia are treated with multicomponent behavioraltherapy, which combines two or more of the common behavioral therapies.

A common pharmacological therapy for treating insomnia is use ofBenzodiazepine Receptor Agonistic Modulators (BzRAs), which act as ahypnotic to induce and maintain sleep.

Another common pharmacological therapy for treating insomnia is use ofNon Benzodiazepine Receptor Agonistic Modulators (Non BzRAs), which actas a hypnotic to induce and maintain sleep.

Another common pharmacological therapy for treating insomnia is use ofmelatonin receptor agonists, which are used primarily for inducingsleep.

Another common pharmacological therapy for treating insomnia is use of alow dose sedating antidepressant, which may be used with comorbiddepression.

Some pharmacological therapies for treating insomnia includecombinations of BzRAs or Non BZRAs and antidepressants.

Some patients with insomnia treat themselves with over-the-counterantihistamines.

Some patients with insomnia treat themselves with over-the-counterantihistamine-analgesic combinations.

Some patients with insomnia treat themselves with over-the-countervalerian extracts.

Some patients with insomnia treat themselves with over-the-countermelatonin.

Another experimental treatment for treating insomnia is cranialelectrotherapy stimulation, which induces a pulsed electric currentthrough the brain using electrodes attached to the scalp or earlobes.

All of the forgoing approaches have disadvantages, which limit theireffectiveness. Pharmacological treatments have complications includingaddiction, amnesia, hallucinations, depression, confusion, suicideideation and daytime sleepiness. Behavioral therapy techniques areexpensive and time consuming, and patients have difficulty complyingwith protocols. Cranial electrotherapy stimulation is used duringdaytime and is not an active therapeutic for inducing or maintainingsleep.

A new treatment is needed that is applied in response to a patient'sindividual physiology, which will actively assist the patient inachieving and maintaining sleep, and which does not have undesirableside effects.

SUMMARY OF THE INVENTION

In accordance with the present invention, providing bilateralstimulation to a patient, independent of the other psychotherapeuticmechanisms together with EMDR, is believed to produce shifts in regionalbrain activation and neuromodulation similar to those produced duringREM sleep thus accelerating the onset of sleep. By analyzing certainphysiological data such as EEG, actigraph or other physiological data itis possible to determine when a patient is aroused from sleep and, undersuch condition applying bilateral stimulation to the patient whichproduces shifts in regional brain activation and neuromodulation similarto those produced during REM sleep thus maintaining the patient's sleepstate.

More specifically, the present invention provides a medical device,which initiates and/or accelerates the onset of sleep, and maintains thesleep state after sleep onset. The device controls delivery of bilateralstimulation to the patient in response to physiological signals receivedfrom the patient. In one embodiment the device includes one or morepatient worn modules, which communicate with a controller.

The patient worn modules typically comprise (a) one or more stimulators;(b) one or more physiological sensors; (c) one or more communicationmechanisms; (d) memory; and (e) a processor, which is coupled to thestimulators, sensors, communication mechanisms and memory. The sensorsare typically coupled to the patient and are designed to detectphysiological signals, which may originate from brain wave activity,body movement, respiration, heart rate, body temperature, blood pressureor other physiological sources, or combinations thereof. The stimulatorsare coupled to the patient and produce a physiological stimulation. Thestimulation may comprise tactile, auditory, visual, neurological orother physiological stimulation, or combinations thereof.

The controller typically comprises (a) a touch sensitive screen; (b) oneor more communication mechanisms; (c) memory; and (d) a processor, whichis coupled to the screen, communication mechanisms and memory.

The controller transmits signals either directly or wirelessly via thecommunication mechanisms to the patient worn modules, which control thebehavior of the stimulators to create a repeating pattern of stimulationin response to feedback from the physiological sensors. The pattern ofstimulation is such that a first stimulator is activated for a period oftime, followed by a period of time when no stimulator is activated,followed by activation of a second stimulator for a period of time(typically on the opposite lateral side of the patient's body, sometimeshereinafter referred to as “alternate bilateral stimulation” or ABS),followed by a period of time when no stimulator is activated.

The controller incorporates user accessible controls, which can be usedmanually to modify the parameters of the signals that are transmitted tothe patient worn modules. Alternatively, the controller may beconfigured to automatically modify the signals that are transmitted tothe patient worn modules in direct response to physiological feedback.These parameters determine the characteristics of the repeating patternof stimulation and may include the duration of time during which thestimulators are activated, the duration of time between successivestimulator activations, the relative intensity of the stimulations, andthe initiation and cessation of the repeating pattern of stimulation.

The sensors are coupled to the patient in such a manner as to be able todetect physiological signals from the patient. The processor in thepatient worn module processes these signals and generates physiologicaldata, which may be periodically transmitted to the controller via thecommunication mechanisms.

The processor in the patient worn module is optionally programmed to usethe physiological data to determine one or more characteristics of thestate of wakefulness of the patient, which may be periodicallytransmitted to the controller via the communication mechanisms. Theprocessor in the patient worn module is also optionally programmed toautomatically alter the characteristics of the repeating pattern ofstimulation in response to one or more characteristics of the state ofwakefulness of the patient.

The processor in the controller is optionally programmed to use thephysiological data transmitted from the patient worn module to determineone or more characteristics of the state of wakefulness of the patient.The processor is also programmed to automatically alter thecharacteristics of the repeating pattern of stimulation in response toone or more characteristics of the state of wakefulness of the patient.

The processor in the controller is also programmed to automaticallyalter the characteristics of the repeating pattern of stimulation inresponse to one or more characteristics of the state of wakefulness ofthe patient transmitted from the patient worn module.

BRIEF DESCRIPTION OF DRAWINGS

The invention will be more fully understood by referring to thefollowing Detailed Description of Specific Embodiments in conjunctionwith the Drawings, of which:

FIG. 1 is a perspective view of a medical device, according to oneembodiment of the present invention, wherein the controller is inwireless communication with two patient worn modules, each comprising astimulator and a physiological sensor, which are attached to separatebelts;

FIG. 2 is a perspective view of a medical device, according to a secondembodiment of the present invention, wherein the controller is inwireless communication with two patient worn modules, each comprising astimulator and a physiological sensor, which are attached to separatebelts, and, the controller is in wireless communication with a thirdpatient worn module comprising a physiological sensor, which is attachedto a third belt;

FIG. 3 is a perspective view of a medical device, according to a thirdembodiment of the present invention, wherein the controller is inwireless communication with two patient worn modules, each comprising astimulator and a physiological sensor, which are attached to separatebelts, and, the controller is in wireless communication with twoadditional patient worn modules comprising a physiological sensor, whichare both attached to a third belt;

FIG. 4 is a perspective view of a medical device, according to a fourthembodiment of the present invention, wherein the controller is inwireless communication with two patient worn modules, each comprising aphysiological sensor, and, the controller is in wireless communicationwith a third patient worn module comprising multiple stimulators,wherein all patient worn modules are attached to the same belt;

FIG. 5 is a perspective view of a medical device, according to a fifthembodiment of the present invention, wherein the controller is inwireless communication with two patient worn modules, each comprising aphysiological sensor, and, the controller is in wireless communicationwith two additional patient worn modules each comprising a stimulator,wherein all four patient worn modules are attached to the same belt,and, the controller is in wireless communication with a fifth patientworn module comprising a physiological sensor which is attached to asecond belt;

FIG. 6 is a block diagram of the controller of FIG. 1, according to oneembodiment of the present invention, wherein the controller is comprisedof a processor, memory, a touch sensitive screen, and wired and wirelesscommunication mechanisms;

FIG. 7 is a block diagram of the patient worn modules of FIG. 1-6,according to one embodiment of the present invention, wherein thepatient worn module is comprised of a processor, memory, wired andwireless communication mechanisms, zero or more stimulators and zero ormore physiological sensors;

FIG. 8 is a flowchart that illustrates operations performed, accordingto one embodiment of the present invention wherein the device isinitiating and/or accelerating the onset of sleep; and

FIG. 9 is a flowchart that illustrates operations performed, accordingto one embodiment of the present invention, wherein the devicedetermines if the patient is transitioning from a state of sleep to astate of wakefulness.

DETAILED DESCRIPTION

Definitions

Insomnia is characterized by a complaint of difficulty initiating sleep,maintaining sleep, and/or nonrestorative sleep that causes clinicallysignificant distress or impairment in social, occupational, or otherimportant areas of functioning.

Cognitive behavior therapy is a form of psychotherapy that emphasizesthe role of thinking in how we feel and what we do. It is based on theidea that our thoughts cause our feelings and behaviors, not externalthings, like people, situations, and events.

Polysomnogram (PSG) is the test result from a Polysomnography study,which is a multi-parametric test used in the study of sleep and as adiagnostic tool in sleep medicine.

Electroencephalography (EEG) is the recording of electrical activity ofthe brain. EEG measures voltage fluctuations resulting from ioniccurrent flows within the neurons of the brain. EEG is one of theparameters employed in a PSG.

EEG sensors are electrodes used to measure the electrical activity ofthe brain during EEG.

Bilateral stimulation is an activity that alternately stimulatesopposite hemispheres of the brain. It may be accomplished in multipleways including applying audio, tactile or visual stimulation alternatelyto opposite lateral sides of the body.

Eye movement desensitization and reprocessing (EMDR) is a form ofpsychotherapy used to resolve the development of trauma-relateddisorders caused by exposure to distressing events such as rape ormilitary combat. EMDR uses a structured eight-phase approach andincorporates bilateral stimulation during one or two of the phases.

A vibration motor is a type of electrical motor used in hand-helddevices to provide tactile feedback to the user in the form ofvibrations. It may be constructed with an eccentric mass counter weightmounted to the shaft of a small circular motor, or a mass mounted to theshaft of a small linear motor. These are commonly used in consumerdevices such as cell phones.

An accelerometer is an electromechanical device that measuresacceleration forces.

An actimetry sensor is a patient worn device, which uses accelerometersto measure gross motor activity.

Actigraphy is a widely accepted technology, which uses actimetry sensorsto determine sleep/wake patterns for the diagnosis and monitoring ofsleep disorders such as insomnia.

An electroactive polymer is a type of material that contracts andexpands when stimulated with an electrical current.

A communication mechanism is a means for two or more electronic devicesto exchange information. This may take multiple forms including standardcomputer interfaces, e.g. USB and LAN, as well as wireless mechanismsincluding Blue Tooth and Zigbee.

FIG. 1 Description

FIG. 1 is a perspective view of one embodiment of the present invention.In this embodiment, a portable, battery powered controller 100 comprisesa portable housing 102 containing electronic circuitry (not visible),which is coupled to two portable, battery powered, patient worn modules110. The controller 100 contains a processor (not visible), which iscoupled to a touch sensitive screen 104, a wired communication port 106,and, one or more wireless communication mechanisms (not visible).

The patient worn modules 110 each contain a processor (not visible),which is coupled to one or more wireless communication mechanisms (notvisible), a stimulator (not visible) and one or more physiologicalsensors (not visible). The stimulator may optionally comprise avibration motor, which may include an eccentric mass counter weightattached to the shaft of a circular motor, which when activated, causesa tactile stimulation when coupled to a patient. The stimulator may alsooptionally comprise a vibration motor, which may include a mass attachedto the shaft of a linear motor, which when activated, causes a tactilestimulation when coupled to a patient. The stimulator may alsooptionally comprise a piezoelectric vibration motor, which whenactivated, causes a tactile stimulation when coupled to a patient. Thestimulator may also optionally comprise a transcutaneous electricalnerve stimulator (TENS), which when activated, causes a neurologicalstimulation when coupled to a patient. The physiological sensors mayoptionally comprise one or more actimetry sensors, which detect grossmotor movement when coupled to a patient. The patient worn modules 110may periodically process data from the physiological sensors andtransmit the resulting data to the controller 100 via the wirelesscommunication mechanisms of each device. The patient worn modules 110may be optionally attached to one or more adjustable belts 112.

The controller 100 is optionally coupled to two patient worn modules 110through the wireless communication mechanisms of each device andcontrols the operation of the patient worn modules 110 to generate arepeating pattern of stimulation. The repeating pattern of stimulationhas a first period of time when the stimulator of a first patient wornmodule 110 is activated followed by a second period of time when neitherstimulator is activated, followed by a third period of time when thestimulator of a second patient worn module 110 is activated, followed bya fourth period of time when neither stimulator is activated.

The controller 100 may automatically adjust the characteristics of therepeating pattern of stimulation in response to physiological datareceived from the patient worn modules 110. The controller 100 mayoptionally automatically adjust the duration of time that eachstimulator is active during each cycle of the repeating pattern ofstimulation. The controller 100 may also optionally automatically adjustthe duration of time that neither stimulator is active during each cycleof the repeating pattern of stimulation. The controller 100 may alsooptionally automatically adjust the relative intensity of thestimulations produced by each stimulator during each cycle of therepeating pattern of stimulation. The controller 100 may also optionallyautomatically terminate or initiate the repeating pattern ofstimulation.

Variable controls may be presented in the user interface on thetouch-sensitive screen 104 which allow the user to adjust thecharacteristics of the repeating pattern of stimulation. The userinterface on the touch-sensitive screen 104 may optionally present avariable control, which the user may adjust to determine the duration oftime that each stimulator is active during each cycle of the repeatingpattern of stimulation. The duration of time that each stimulator isactive during each cycle of the repeating pattern of stimulation mayoptionally be configured to a value between 10 milliseconds and 100milliseconds, with a nominal value of 50 milliseconds. The duration oftime that each stimulator is active during each cycle of the repeatingpattern of stimulation may optionally be configured to a value between100 milliseconds and 500 milliseconds, with a nominal value of 250milliseconds. The duration of time that each stimulator is active duringeach cycle of the repeating pattern of stimulation may optionally beconfigured to a value between 500 milliseconds and 1000 milliseconds,with a nominal value of 750 milliseconds. The duration of time that eachstimulator is active during each cycle of the repeating pattern ofstimulation may optionally be configured to a value between 1000milliseconds and 2000 milliseconds, with a nominal value of 1500milliseconds. The duration of time that each stimulator is active duringeach cycle of the repeating pattern of stimulation may optionally beconfigured to a value between 2000 milliseconds and 3000 milliseconds,with a nominal value of 2500 milliseconds. The user interface on thetouch-sensitive screen 104 may also optionally present a variablecontrol, which the user may adjust to determine the duration of timethat neither stimulator is active during each cycle of the repeatingpattern of stimulation. The duration of time that neither stimulator isactive during each cycle of the repeating pattern of stimulation mayoptionally be configured to a value between 10 milliseconds and 100milliseconds, with a nominal value of 50 milliseconds. The duration oftime that neither stimulator is active during each cycle of therepeating pattern of stimulation may optionally be configured to a valuebetween 100 milliseconds and 500 milliseconds, with a nominal value of250 milliseconds. The duration of time that neither stimulator is activeduring each cycle of the repeating pattern of stimulation may optionallybe configured to a value between 500 milliseconds and 1000 milliseconds,with a nominal value of 750 milliseconds. The duration of time thatneither stimulator is active during each cycle of the repeating patternof stimulation may optionally be configured to a value between 1000milliseconds and 2000 milliseconds, with a nominal value of 1500milliseconds. The duration of time that neither stimulator is activeduring each cycle of the repeating pattern of stimulation may optionallybe configured to a value between 2000 milliseconds and 3000milliseconds, with a nominal value of 2500 milliseconds. The userinterface on the touch-sensitive screen 104 may also optionally presenta variable control, which the user may adjust to determine the relativeintensity of the stimulations produced by each stimulator during eachcycle of the repeating pattern of stimulation. The user interface on thetouch-sensitive screen 104 may also optionally present a variablecontrol, which the user may adjust to determine the length of time afterwhich the controller 100 will terminate the repeating pattern ofstimulation and to subsequently periodically monitor physiological datareceived from the patient worn modules 110 to determine if the patientis becoming aroused from sleep and to consequently resume the repeatingpattern of stimulation. The length of time after which the controller100 will terminate the repeating pattern of stimulation and subsequentlyperiodically monitor physiological data received from the patient wornmodules 110 to determine if the patient is becoming aroused from sleepand consequently resume the repeating pattern of stimulation mayoptionally be configured to a value between 10 minutes and 20 minutes,with a nominal value of 15 minutes. The length of time after which thecontroller 100 will terminate the repeating pattern of stimulation andsubsequently periodically monitor physiological data received from thepatient worn modules 110 to determine if the patient is becoming arousedfrom sleep and consequently resume the repeating pattern of stimulationmay optionally be configured to a value between 20 minutes and 30minutes, with a nominal value of 25 minutes. The length of time afterwhich the controller 100 will terminate the repeating pattern ofstimulation and subsequently periodically monitor physiological datareceived from the patient worn modules 110 to determine if the patientis becoming aroused from sleep and consequently resume the repeatingpattern of stimulation may optionally be configured to a value between30 minutes and 40 minutes, with a nominal value of 35 minutes. Thelength of time after which the controller 100 will terminate therepeating pattern of stimulation and subsequently periodically monitorphysiological data received from the patient worn modules 110 todetermine if the patient is becoming aroused from sleep and consequentlyresume the repeating pattern of stimulation may optionally be configuredto a value between 40 minutes and 50 minutes, with a nominal value of 45minutes. The length of time after which the controller 100 willterminate the repeating pattern of stimulation and subsequentlyperiodically monitor physiological data received from the patient wornmodules 110 to determine if the patient is becoming aroused from sleepand consequently resume the repeating pattern of stimulation mayoptionally be configured to a value between 50 minutes and 60 minutes,with a nominal value of 55 minutes. The length of time after which thecontroller 100 will terminate the repeating pattern of stimulation andsubsequently periodically monitor physiological data received from thepatient worn modules 110 to determine if the patient is becoming arousedfrom sleep and consequently resume the repeating pattern of stimulationmay optionally be configured to a value between 60 minutes and 90minutes, with a nominal value of 75 minutes. The user interface on thetouch-sensitive screen 104 may also optionally present a variablecontrol, which the user may adjust to determine the length of time afterwhich the controller 100 will terminate the repeating pattern ofstimulation and will not periodically monitor physiological datareceived from the patient worn modules 110 to determine if the patientis becoming aroused from sleep. The length of time after which thecontroller 100 will terminate the repeating pattern of stimulation andwill not periodically monitor physiological data received from thepatient worn modules 110 to determine if the patient is becoming arousedfrom sleep may optionally be configured to a value between 10 minutesand 40 minutes, with a nominal value of 25 minutes. The length of timeafter which the controller 100 will terminate the repeating pattern ofstimulation and will not periodically monitor physiological datareceived from the patient worn modules 110 to determine if the patientis becoming aroused from sleep may optionally be configured to a valuebetween 40 minutes and 80 minutes, with a nominal value of 60 minutes.The length of time after which the controller 100 will terminate therepeating pattern of stimulation and will not periodically monitorphysiological data received from the patient worn modules 110 todetermine if the patient is becoming aroused from sleep may optionallybe configured to a value between 80 minutes and 160 minutes, with anominal value of 120 minutes. The length of time after which thecontroller 100 will terminate the repeating pattern of stimulation andwill not periodically monitor physiological data received from thepatient worn modules 110 to determine if the patient is becoming arousedfrom sleep may optionally be configured to a value between 160 minutesand 320 minutes, with a nominal value of 240 minutes. The length of timeafter which the controller 100 will terminate the repeating pattern ofstimulation and will not periodically monitor physiological datareceived from the patient worn modules 110 to determine if the patientis becoming aroused from sleep may optionally be configured to a valuebetween 320 minutes and 640 minutes, with a nominal value of 480minutes. The length of time after which the controller 100 willterminate the repeating pattern of stimulation and will not periodicallymonitor physiological data received from the patient worn modules 110 todetermine if the patient is becoming aroused from sleep may optionallybe configured to a value between 480 minutes and 720 minutes, with anominal value of 600 minutes.

Controls may be presented in the user interface on the touch-sensitivescreen 104 which allow the user to select a preconfigured initial set ofcharacteristics of the repeating pattern of stimulation including theduration of time that each stimulator is active during each cycle of therepeating pattern of stimulation, the duration of time that neitherstimulator is active during each cycle of the repeating pattern ofstimulation, the relative intensity of the stimulations, the length oftime after which the controller 100 will terminate the repeating patternof stimulation and subsequently periodically monitor physiological datareceived from the patient worn modules 110 to determine if the patientis becoming aroused from sleep and to consequently resume the repeatingpattern of stimulation, and the length of time after which thecontroller 100 will terminate the repeating pattern of stimulation andwill not periodically monitor physiological data received from thepatient worn modules 110 to determine if the patient is becoming arousedfrom sleep.

In a typical context in which the controller 100 and two patient wornmodules 110 are used, a patient prepares for sleep and attaches eachpatient worn module 110 to a separate adjustable belt 112, secures oneadjustable belt around each wrist and applies power to each patient wornmodule 110 by activating a power control (not visible). The patientapplies power to the controller 100 by activating control 108 and thecontroller establishes wireless communication with each of the patientworn modules using the wireless communication mechanisms of each device.The patient adjusts the previously mentioned controls on the touchsensitive screen 104 to set the initial characteristics of the repeatingpattern of stimulation and the controller 100 initiates the repeatingpattern of stimulation. The patient then attempts to initiate sleep. Thecontroller 100 will terminate the repeating pattern of stimulation afterthe period of time set by the patient.

Subsequent to the initiation of the repeating pattern of stimulation,the processor in each patient worn module 110 periodically processessignals received from the actimetry sensors to generate relativeposition data, optionally stores this data in sequential order to createa sequential relative patient position data store, and optionallytransmits this data to the controller 100 through the wirelesscommunication mechanism of each device, wherein the controller 100stores this data in sequential order to create a sequential relativepatient position data store. The period of time between subsequentgenerations of relative patient position data may optionally beconfigured to a value between 1 and 120 seconds, with a nominal value of60 seconds. The period of time between subsequent generations ofrelative patient position data may also optionally be configured to avalue between 1 and 60 seconds, with a nominal value of 30 seconds. Theperiod of time between subsequent generations of relative patientposition data may also optionally be configured to a value between 1 and30 seconds, with a nominal value of 10 seconds. The period of timebetween subsequent generations of relative patient position data mayalso optionally be configured to a value between 1 and 10 seconds, witha nominal value of 1 second.

The processor in each patient worn module 110 also optionallyperiodically processes the sequential relative patient position datastore and generates data indicative of the number of gross motormovements experienced by the patient over a defined period of time,optionally stores this data in sequential order to create a sequentialpatient movement data store, and optionally transmits this data to thecontroller 100 through the wireless communication mechanism of eachdevice, wherein the controller 100 stores this data in sequential orderto create a sequential patient movement data store. Alternatively, theprocessor in the controller 100 periodically processes the sequentialrelative patient position data store and generates data indicative ofthe number of gross motor movements experienced by the patient over adefined period of time, and stores this data in sequential order tocreate a sequential patient movement data store. The defined period oftime over which the number of gross motor movements experienced by thepatient is determined, may optionally be configured to a value between 1and 360 seconds, with a nominal value of 180 seconds. The defined periodof time over which the number of gross motor movements experienced bythe patient is determined, may also optionally be configured to a valuebetween 1 and 240 seconds, with a nominal value of 120 seconds. Thedefined period of time over which the number of gross motor movementsexperienced by the patient is determined, may also optionally beconfigured to a value between 1 and 120 seconds, with a nominal value of60 seconds. The defined period of time over which the number of grossmotor movements experienced by the patient is determined, may alsooptionally be configured to a value between 1 and 60 seconds, with anominal value of 30 seconds.

Optionally the processor in each patient worn module 110 and optionallythe processor in the controller 100 compare sequential relative positiondata in the sequential relative patient position data store anddetermines that the patient has experienced a gross motor movement ifthe difference between the sequential relative positions exceeds adefined threshold. The defined threshold for determining that thepatient has experienced a gross motor movement may optionally beconfigured to a value between 5 and 400 millimeters, with a nominalvalue of 200 millimeters. The defined threshold for determining that thepatient has experienced a gross motor movement may also optionally beconfigured to a value between 5 and 200 millimeters, with a nominalvalue of 100 millimeters. The defined threshold for determining that thepatient has experienced a gross motor movement may also optionally beconfigured to a value between 5 and 100 millimeters, with a nominalvalue of 50 millimeters. The defined threshold for determining that thepatient has experienced a gross motor movement may also optionally beconfigured to a value between 5 and 50 millimeters, with a nominal valueof 25 millimeters.

Additionally, subsequent to the initiation of the repeating pattern ofstimulation, the processor in each patient worn module 110 alsooptionally periodically processes the sequential patient movement datastore and generates data indicative of the wakefulness of the patientand stores this data in sequential order to create a sequential patientwakefulness data store, and optionally transmits this data to thecontroller 100 through the wireless communication mechanism of eachdevice, wherein the controller 100 stores this data in sequential orderto create a sequential patient wakefulness data store. Alternatively,the processor in the controller 100 periodically processes thesequential patient movement data store and generates data indicative ofthe wakefulness of the patient and stores this data in sequential orderto create a sequential patient wakefulness data store. The period oftime between subsequent generations of data indicative of thewakefulness of the patient may optionally be configured to a valuebetween 1 and 360 seconds, with a nominal value of 180 seconds. Theperiod of time between subsequent generations of data indicative of thewakefulness of the patient may also optionally be configured to a valuebetween 1 and 240 seconds, with a nominal value of 120 seconds. Theperiod of time between subsequent generations of data indicative of thewakefulness of the patient may also optionally be configured to a valuebetween 1 and 120 seconds, with a nominal value of 60 seconds. Theperiod of time between subsequent generations of data indicative of thewakefulness of the patient may also optionally be configured to a valuebetween 1 and 60 seconds, with a nominal value of 30 seconds.

The processor in the controller 100 and optionally the processor in eachpatient worn module 110 compare the number of gross motor movementsexperienced by the patient over a defined period to a defined thresholdto generate data indicative of the wakefulness of the patient. If thenumber of gross motor movements experienced by the patient over adefined period exceeds the defined threshold, the wakefulness of thepatient is set to awake. If the number of gross motor movementsexperienced by the patient over a defined period is less than or equalto the defined threshold, the wakefulness of the patient is set toasleep. The defined threshold of gross motor movements experienced bythe patient over a defined period for determining the wakefulness of thepatient may optionally be configured to a value between 1 and 20 grossmotor movements experienced by the patient over a defined period, with anominal value of 10. The defined threshold of gross motor movementsexperienced by the patient over a defined period for determining thewakefulness of the patient may also optionally be configured to a valuebetween 1 and 10 gross motor movements experienced by the patient over adefined period, with a nominal value of 5. The defined threshold ofgross motor movements experienced by the patient over a defined periodfor determining the wakefulness of the patient may also optionally beconfigured to a value between 1 and 5 gross motor movements experiencedby the patient over a defined period, with a nominal value of 2.

Additionally, subsequent to the initiation of the repeating pattern ofstimulation, the processor in the controller 100 periodically processesthe sequential patient wakefulness data store and generates a pattern ofpatient wakefulness. Optionally, subsequent to the initiation of therepeating pattern of stimulation, the processor in each patient wornmodule 110 periodically process the sequential patient wakefulness datastore and generates a pattern of patient wakefulness and transmits thisdata to the controller 100 through the wireless communication mechanismof each device. The pattern of patient wakefulness may consist of aconfigurable number of the most recent data elements in the sequentialpatient wakefulness data store. The number of the most recent dataelements in the sequential patient wakefulness data store used togenerate the pattern of patient wakefulness may optionally be configuredto a value between 1 and 30 elements with a nominal value of 15. Thenumber of the most recent data elements in the sequential patientwakefulness data store used to generate the pattern of patientwakefulness may also optionally be configured to a value between 1 and20 elements with a nominal value of 10. The number of the most recentdata elements in the sequential patient wakefulness data store used togenerate the pattern of patient wakefulness may also optionally beconfigured to a value between 1 and 10 elements with a nominal value of5. The processor may also optionally modify the number of most recentdata elements in the sequential patient wakefulness data store that isused to generate the pattern of patient wakefulness in response tovalues in the pattern of patient wakefulness. For example, if thepattern of patient wakefulness oscillates between states of asleep andawake, the processor may increase the number of most recent dataelements in the sequential patient wakefulness data store that is usedto generate the pattern of patient wakefulness.

The processor in the controller 100 may optionally modify thecharacteristics of the repeating pattern of stimulation in response tochanges in the pattern of patient wakefulness. By way of example, if thepercentage of data elements in the pattern of patient wakefulnessindicating the patient is asleep increases between subsequent patternsof patient wakefulness, the processor may reduce the relative intensityof the stimulations of the repeating pattern of stimulation. By way ofanother example, if the percentage of data elements in the pattern ofpatient wakefulness indicating the patient is asleep exceeds aconfigurable threshold, the processor may terminate the repeatingpattern of stimulation. By way of another example, if the repeatingpattern of stimulation has been previously terminated and the percentageof data elements in the pattern of patient wakefulness indicating thepatient is awake increases above a configurable threshold, the processormay re-initiate the repeating pattern of stimulation. By way of anotherexample, if the repeating pattern of stimulation is currently active andthe number of data elements in the pattern of patient wakefulnessindicating the patient is awake, increases between subsequent patternsof patient wakefulness, the processor may optionally increase therelative intensify of the repeating pattern of stimulation.

FIG. 2 Description

FIG. 2 is a perspective view of a second embodiment of the presentinvention. In this embodiment a portable, battery powered controller 100as previously described in FIG. 1 is coupled to two portable, batterypowered, patient worn modules 210 and to one portable, battery powered,patient worn module 204.

The patient worn modules 210 each contain a processor (not visible),which is coupled to one or more wireless communication mechanisms (notvisible), a stimulator (not visible) and one or more physiologicalsensors (not visible). The stimulator may optionally comprise anelectroactive polymer, which responds to an induced electrical currentby contracting, and which, when so activated, causes a tactilestimulation when coupled to a patient. The physiological sensors mayoptionally comprise one or more actimetry sensors, which detect grossmotor movement when coupled to a patient. The processor in the patientworn modules 210 may periodically process data from the actimetrysensors and transmit the resulting data to the controller via thewireless communication mechanisms of each device. The patient wornmodules 210 may be optionally attached to one or more adjustable belts212.

The patient worn module 204 contains a processor (not visible), which iscoupled to one or more wireless communication mechanisms (not visible),and one or more physiological sensors (not visible). The physiologicalsensors may optionally comprise a respiratory sensor, which measures thepatient's respiration rate when coupled to the patient. The processor inthe patient worn module 204 may periodically process data from therespiratory sensor and transmit the resulting data to the controller viathe wireless communication mechanisms of each device. The patient wornmodule 204 may be optionally attached to an adjustable belt 206.

The controller 100 is optionally coupled to the two patient worn modules210 through the wireless communication mechanisms of each device, and,the controller 100 is optionally coupled to the patient worn module 204through the wireless communication mechanisms of each device.

The controller 100 controls the operation of the two patient wornmodules 210 to generate a repeating pattern of stimulation. Therepeating pattern of stimulation is as described previously in FIG. 1.

The controller 100 may automatically adjust the characteristics of therepeating pattern of stimulation in response to physiological datareceived from the patient worn modules 210 and 204. The controller 100may optionally automatically adjust the duration of time that eachstimulator is active during each cycle of the repeating pattern ofstimulation. The controller 100 may also optionally automatically adjustthe duration of time that neither stimulator is active during each cycleof the repeating pattern of stimulation. The controller 100 may alsooptionally automatically adjust the relative intensity of thestimulations produced by each stimulator during each cycle of therepeating pattern of stimulation. The controller 100 may also optionallyautomatically terminate or initiate the repeating pattern ofstimulation.

Variable controls may be presented in the user interface on thecontroller 100, which control the initial characteristics of therepeating pattern of stimulation as described previously in FIG. 1.

Controls may also be presented in the user interface on the controller100 which allow the user to select a preconfigured initial set ofcharacteristics of the repeating pattern of stimulation as describedpreviously in FIG. 1.

In a typical context in which the controller 100 and two patient wornmodules 210, and, one patient worn module 204 are used, a patientprepares for sleep and attaches the patient worn module 204 to a singleadjustable belt 206 and secures the adjustable belt around the patient'storso such that the module 204 is positioned to detect the patient'srespiration rate. The patient also attaches each patient worn module 210to separate adjustable belts 212, and secures one to each wrist asdescribed previously in FIG. 1. The patient applies power to each of thepatient worn modules 210 and 204 by activating a power control (notvisible). The patient applies power to the controller 100 and thecontroller establishes wireless communication with each of the patientworn modules using the wireless communication mechanisms of each device.The patient adjusts the previously mentioned controls on the controller100 to set the initial characteristics of the repeating pattern ofstimulation, and initiates the repeating pattern of stimulation asdescribed previously in FIG. 1. The patient then attempts to initiatesleep. The controller 100 will terminate the repeating pattern ofstimulation after the period of time set by the patient as describedpreviously in FIG. 1.

Subsequent to the initiation of the repeating pattern of stimulation,the processor in each patient worn module 210 periodically processessignals received from the actimetry sensor to generate data indicativeof the relative patient position data, and optionally the number ofgross motor movements experienced by the patient over a defined periodof time, the wakefulness of the patient, and a pattern of patientwakefulness, and, transmits this data to the controller 100 through thewireless communication mechanisms of each device as described previouslyin FIG. 1.

Additionally, subsequent to the initiation of the repeating pattern ofstimulation, the processor in the controller 100 periodically optionallyprocesses the data received from each patient worn module 210 (e.g.indicative of the number of gross motor movements experienced by thepatient over a defined period of time) and generates a pattern ofpatient wakefulness as described previously in FIG. 1. The processor inthe controller 100 may optionally modify the characteristics of therepeating pattern of stimulation in response to changes in the patternof patient wakefulness as described previously in FIG. 1.

Additionally, subsequent to the initiation of the repeating pattern ofstimulation, the processor in the patient worn module 204 periodicallyprocesses signals received from the respiratory sensor, and generatesdata indicative of the patient's respiration rate, and transmits thisdata to the controller 100 through the wireless communication mechanismof each device.

Additionally, subsequent to the initiation of the repeating pattern ofstimulation, the processor in the controller 100 periodically processesthe data indicative of the patient's respiration rate and stores thisdata in sequential order to create a sequential patient respiration ratedata store. The processor in the controller 100 periodically processesthe sequential patient respiration rate data store and generates apattern of patient respiration rate. The pattern of patient respirationrate may consist of a configurable number of the most recent dataelements in the sequential patient respiration rate data store. Thenumber of the most recent data elements in the sequential patientrespiration rate data store used to generate the pattern of patientrespiration rate may optionally be configured to a value between 1 and30 elements with a nominal value of 15. The number of the most recentdata elements in the sequential patient respiration rate data store usedto generate the pattern of patient respiration rate may also optionallybe configured to a value between 1 and 20 elements with a nominal valueof 10. The number of the most recent data elements in the sequentialpatient respiration rate data store used to generate the pattern ofpatient respiration rate may also optionally be configured to a valuebetween 1 and 10 elements with a nominal value of 5. The processor mayalso optionally modify the number of most recent data elements in thesequential patient respiration rate data store that is used to generatethe pattern of patient respiration rate in response to values in thepattern of patient respiration rate. For example, if the pattern ofpatient respiration rate contains values that are erratic or otherwisenot consistent between two or more sequential values, the processor mayincrease the number of most recent data elements in the sequentialpatient respiration rate data store that is used to generate the patternof patient respiration rate.

It will be understood by one skilled in the art that the generation ofthe previously described physiological data, including the sequentialpatient respiration rate data store, and the pattern of patientrespiration rate, may optionally be performed by the processor in thepatient worn module 204 in coordination with the processor in thecontroller 100.

The processor in the controller 100 may optionally store one or morevalues of the patient respiration rate in long-term storage, which areavailable to the processor following subsequent cycling of power to thecontroller 100. The processor may store values of the patientrespiration rate in long-term storage, which are indicative of therespiration rate of the patient corresponding to specific patterns ofwakefulness that are described previously in FIG. 1. The processor inthe controller 100 may optionally modify the characteristics of therepeating pattern of stimulation in response to the values in thepattern of patient respiration rate and the values of the patientrespiration rate in long-term storage. By way of example, if the mostrecent pattern of patient respiration rate has an average value thatexceeds the value of the patient respiration rate corresponding to awakefulness state of asleep in long term storage, the controller 100 mayoptionally modify the characteristics of the repeating pattern ofstimulation such that the rate of the repeating pattern of stimulationis a configurable percentage lower than the average value of the mostrecent pattern of patient respiration rate. The percentage by which thecontroller 100 modifies the rate of the repeating pattern of stimulationmay be configured between 10% and 50% with a nominal value of 25%. Thepercentage by which the controller 100 modifies the rate of therepeating pattern of stimulation may also be optionally modified inresponse to the relative difference between the average value of themost recent pattern of patient respiration rate and the value of thepatient respiration rate corresponding to a wakefulness state of asleepin long term storage.

It will be understood by one skilled in the art that the data used forcomparison with the most recent pattern of patient respiration rate forpurposes of modifying the characteristics of the repeating pattern ofstimulation may derive from sources other than the patient. For example,rather than using values of the patient respiration rate correspondingto a specific state of wakefulness stored in long term storage,published data for normal patient respiration rate values correspondingto a specific state of wakefulness may be used.

FIG. 3 Description

FIG. 3 is a perspective view of a third embodiment of the presentinvention. In this embodiment a portable, battery powered controller 100as previously described in FIG. 1 is coupled to two portable, batterypowered, patient worn modules 310 and to two portable, battery powered,patient worn modules 302.

The patient worn modules 310 each contain a processor (not visible),which is coupled to one or more wireless communication mechanisms (notvisible), a stimulator (not visible) and one or more physiologicalsensors (not visible). The stimulator may optionally comprise one ormore transcutaneous electrical nerve stimulators (TENS), which produce amild electrical current, and which, when activated, cause a stimulationof the patient's nerves when coupled to a patient. The physiologicalsensors may optionally comprise one or more heart rate sensors, whichdetect the patient's heart rate when coupled to a patient. Theprocessors in the patient worn modules 310 may periodically process datafrom the heart rate sensor and transmit the resulting data to thecontroller 100 via the wireless communication mechanisms of each device.The patient worn modules 310 may be optionally attached to one or moreadjustable belts 312.

The patient worn modules 302 each contain a processor (not visible),which is coupled to one or more wireless communication mechanisms (notvisible) and one or more physiological sensors (not visible). Thephysiological sensors may optionally comprise one or moreElectroencephalography (EEG) sensors, which detect the patient's brainwave activity when coupled to a patient. The processors in the patientworn modules 302 may periodically process data from the EEG sensors andtransmit the resulting data to the controller 100 via the wirelesscommunication mechanisms of each device. The patient worn modules 302may be optionally attached to a single adjustable belt 304.

The controller 100 is optionally coupled to the two patient worn modules310 through the wireless communication mechanisms of each device, and,the controller 100 is optionally coupled to the two patient worn modules302 through the wireless communication mechanisms of each device.

The controller 100 controls the operation of the two patient wornmodules 310 to generate a repeating pattern of stimulation. Therepeating pattern of stimulation is as described previously in FIG. 1.

The controller 100 may automatically adjust the characteristics of therepeating pattern of stimulation in response to physiological datareceived from the patient worn modules 310 and 302. The controller 100may optionally automatically adjust the duration of time that eachstimulator is active during each cycle of the repeating pattern ofstimulation. The controller 100 may also optionally automatically adjustthe duration of time that neither stimulator is active during each cycleof the repeating pattern of stimulation. The controller 100 may alsooptionally automatically adjust the relative intensity of thestimulations produced by each stimulator during each cycle of therepeating pattern of stimulation. The controller 100 may also optionallyautomatically terminate or initiate the repeating pattern ofstimulation.

Variable controls may be presented in the user interface on thecontroller 100, which control the initial characteristics of therepeating pattern of stimulation as described previously in FIG. 1.

Controls may also be presented in the user interface on the controller100 which allow the user to select a preconfigured initial set ofcharacteristics of the repeating pattern of stimulation as describedpreviously in FIG. 1.

In a typical context in which the controller 100 and two patient wornmodules 310, and, two patient worn modules 302 are used, a patientprepares for sleep and attaches the patient worn modules 302 to a singleadjustable belt 304 and secures the adjustable belt around the patient'shead such that the patient worn modules 302 are positioned to detect theelectrical activity of the patient's brain. The patient attaches eachpatient worn module 310 to a separate adjustable belt 312, and securesone to each wrist such that the heart rate sensors are positioned todetect the patient's heart rate and the TENS are positioned to provideelectrical nerve stimulation, in one embodiment on the inside of thewrist. The patient applies power to each of the patient worn modules 310and 302, by activating a control (not visible). The patient appliespower to the controller 100 and the controller establishes wirelesscommunication with each of the patient worn modules using the wirelesscommunication mechanisms of each device. The patient adjusts thepreviously mentioned controls on the controller 100 to set the initialcharacteristics of the repeating pattern of stimulation, and initiatesthe repeating pattern of stimulation as described previously in FIG. 1.The patient then attempts to initiate sleep. The controller 100 willterminate the repeating pattern of stimulation after the period of timeset by the patient as described previously in FIG. 1.

Subsequent to the initiation of the repeating pattern of stimulation,the processor in each patient worn module 302 periodically processessignals received from the EEG sensors and generates data indicative ofthe electrical activity of the patient's brain, and stores this data insequential order to create a sequential patient brain electricalactivity data store. Each processor periodically processes thesequential patient brain electrical activity data store and generatesthe spectral power density for multiple configurable frequency ranges,with four nominal frequency ranges defined as 0.5<δ<4 Hz, 4<θ<8 Hz,8<α<13.0 Hz, 13.0<β<28.0 Hz and transmits this data to the controller100 through the wireless communication mechanisms of each device. Theprocessor in each patient worn module 302 may optionally calculate thespectral power density using a Fast Fourier Transform.

The processor in the controller 100 stores the spectral power densitydata in sequential order to create a sequential spectral power densitydata store. Additionally, the processor in the controller 100periodically processes the sequential spectral power density data storeto compute the relative spectral power of each of the frequency rangesand stores this data in sequential order to create a sequential relativespectral power data store.

Additionally, the processor in the controller 100 periodically processesthe sequential relative spectral power data store and generates apattern of relative spectral power for each of the defined frequencyranges. The number of the most recent data elements in the sequentialrelative spectral power data store used to generate the pattern ofrelative spectral power may optionally be configured to a value between1 and 30 elements with a nominal value of 15. The number of the mostrecent data elements in the sequential relative spectral power datastore used to generate the pattern of relative spectral power may alsooptionally be configured to a value between 1 and 20 elements with anominal value of 10. The number of the most recent data elements in thesequential relative spectral power data store used to generate thepattern of relative spectral power may also optionally be configured toa value between 1 and 10 elements with a nominal value of 5. Theprocessor may also optionally modify the number of most recent dataelements in the sequential relative spectral power data store that isused to generate the pattern of relative spectral power in response tovalues in the pattern of relative spectral power. For example, if thepattern of relative spectral power contains values that are erratic orotherwise not consistent between two or more sequential values, theprocessor may increase the number of most recent data elements in thesequential relative spectral power data store that is used to generatethe pattern of relative spectral power.

Additionally, the processor in the controller 100 periodically comparesthe pattern of relative spectral power for each of the defined frequencyranges and generates data indicative of the wakefulness of the patientand stores this data in sequential order to create a sequential patientwakefulness data store. The period of time between subsequentgenerations of data indicative of the wakefulness of the patient mayoptionally be configured to a value between 1 and 360 seconds, with anominal value of 180 seconds. The period of time between subsequentgenerations of data indicative of the wakefulness of the patient mayalso optionally be configured to a value between 1 and 240 seconds, witha nominal value of 120 seconds. The period of time between subsequentgenerations of data indicative of the wakefulness of the patient mayalso optionally be configured to a value between 1 and 120 seconds, witha nominal value of 60 seconds. The period of time between subsequentgenerations of data indicative of the wakefulness of the patient mayalso optionally be configured to a value between 1 and 60 seconds, witha nominal value of 30 seconds.

By way of example, if the relative spectral power for the β range offrequencies is smaller than the relative spectral power for the δfrequency range the wakefulness of the patient is set to asleep, and, ifthe relative spectral power for the β range of frequencies is largerthan the relative spectral power for the δ frequency range thewakefulness of the patient is set to awake.

Additionally, subsequent to the initiation of the repeating pattern ofstimulation, the processor in the controller 100 periodically comparesthe values in the patterns of relative spectral power for the frequencyranges and may optionally modify the characteristics of the repeatingpattern of stimulation in response to these values.

By way of example, if the processor determines that the pattern ofrelative spectral power for the δ frequency range is increasing, and thepattern of relative spectral power for the α frequency range isdecreasing, and the value of the most recent relative spectral power forthe α range of frequencies is larger than the most recent value for therelative spectral power for the δ range of frequencies, indicating thepatient may be approaching a sleep state, the controller 100 mayoptionally reduce the relative intensity of the stimulations of therepeating pattern of stimulation.

By way of another example, if the processor determines that the patternof relative spectral power for the δ frequency range is increasing, andthe pattern of relative spectral power for the α frequency range isdecreasing, and the value of the most recent relative spectral power forthe α range of frequencies is smaller than the most recent value for therelative spectral power for the δ range of frequencies, indicating thepatient may be in a sleep state, the controller 100 may optionallyterminate the repeating pattern of stimulations.

By way of another example, if the processor determines that the patternof relative spectral power for the δ frequency range is increasing, andthe pattern of relative spectral power for the θ frequency range isdecreasing, and the value of the most recent relative spectral power forthe θ range of frequencies is larger than the most recent value for therelative spectral power for the δ range of frequencies, indicating thepatient may be approaching a sleep state, the controller 100 mayoptionally reduce the relative intensity of the stimulations of therepeating pattern of stimulation.

By way of another example, if the processor determines that the patternof relative spectral power for the δ frequency range is increasing, andthe pattern of relative spectral power for the θ frequency range isdecreasing, and the value of the most recent relative spectral power forthe θ range of frequencies is smaller than the most recent value for therelative spectral power for the δ range of frequencies, indicating thepatient may be in a sleep state, the controller 100 may optionallyterminate the repeating pattern of stimulations.

By way of another example, if the processor determines that the patternof relative spectral power for the δ frequency range is increasing, andthe pattern of relative spectral power for the β frequency range isdecreasing, and the value of the most recent relative spectral power forthe β range of frequencies is larger than the most recent value for therelative spectral power for the δ range of frequencies, indicating thepatient may be approaching a sleep state, the controller 100 mayoptionally reduce the relative intensity of the stimulations of therepeating pattern of stimulation.

By way of another example, if the processor determines that the patternof relative spectral power for the δ frequency range is increasing, andthe pattern of relative spectral power for the β frequency range isdecreasing, and the value of the most recent relative spectral power forthe β range of frequencies is smaller than the most recent value for therelative spectral power for the δ range of frequencies, indicating thepatient may be in a sleep state, the controller 100 may optionallyterminate the repeating pattern of stimulation.

By way of another example, if the processor determines that the patternof relative spectral power for the δ frequency range is decreasing, andthe pattern of relative spectral power for the β frequency range isincreasing, and the value of the most recent relative spectral power forthe β range of frequencies is smaller than the most recent value for therelative spectral power for the δ range of frequencies, indicating thepatient may becoming aroused from sleep, the controller 100 mayoptionally re-initiate the repeating pattern of stimulation.

By way of another example, if the processor determines that the patternof relative spectral power for the δ frequency range is decreasing, andthe pattern of relative spectral power for the β frequency range isincreasing, and the value of the most recent relative spectral power forthe β range of frequencies is larger than the most recent value for therelative spectral power for the δ range of frequencies, indicating thepatient may have awakened from sleep, the controller 100 may optionallyincrease the relative intensity of the stimulations of the repeatingpattern of stimulation.

The processor may optionally store one or more values of the patientspectral power density data in long term storage, which is available tothe processor following subsequent cycling of power to the controller100. The processor may store values of the spectral power density datain long-term storage, which are indicative of the spectral power densitydata of the patient corresponding to specific patterns of wakefulnessthat are described previously. The controller 100 may optionally modifythe characteristics of the repeating pattern of stimulation in responseto the values in the pattern of patient spectral power density data andthe values of the patient spectral power density data corresponding tospecific patterns of wakefulness in long-term storage. By way ofexample, if the most recent pattern of patient spectral power densitydata begins to approximate the patient spectral power density datacorresponding to a wakefulness state of asleep in long term storage, thecontroller 100 may reduce the relative intensity of the stimulations ofthe repeating pattern of stimulation. By way of another example, if themost recent pattern of patient spectral power density data approximatesthe patient spectral power density data corresponding to a wakefulnessstate of asleep in long term storage, the processor may terminate therepeating pattern of stimulation.

It will be understood by one skilled in the art that the data used forcomparison with the most recent pattern of patient spectral powerdensity data for purposes of modifying the characteristics of therepeating pattern of stimulation may derive from sources other than thepatient. For example, rather than using values of the patient spectralpower density data corresponding to a specific state of wakefulnessstored in long term storage, published data for normal patient spectralpower density values corresponding to a specific state of wakefulnessmay be used.

It will be understood by one skilled in the art that the generation ofthe previously described physiological data, including the sequentialpatient brain electrical activity data store, the spectral power densityfor multiple configurable frequency ranges, the sequential spectralpower density data store, the sequential relative spectral power datastore, the pattern of relative spectral power for each of the definedfrequency ranges, and, the sequential patient wakefulness data store mayoptionally be performed by the processor in each of the patient wornmodules 302 in coordination with the processor in the controller 100.

Additionally, subsequent to the initiation of the repeating pattern ofstimulation, the processor in the patient worn module 310 periodicallyprocesses signals received from the heart rate sensor, and generatesdata indicative of the patient's heart rate, and transmits this data tothe controller 100 through the wireless communication mechanisms of eachdevice.

Additionally, subsequent to the initiation of the repeating pattern ofstimulation, the processor in the controller 100 periodically processesthe data indicative of the patient's heart rate and stores this data insequential order to create a sequential patient heart rate data store.The processor in the controller 100 periodically processes thesequential patient heart rate data store and generates a pattern ofpatient heart rate. The pattern of patient heart rate may consist of aconfigurable number of the most recent data elements in the sequentialpatient heart rate data store. The number of the most recent dataelements in the sequential patient heart rate data store used togenerate the pattern of patient heart rate may optionally be configuredto a value between 1 and 30 elements with a nominal value of 15. Thenumber of the most recent data elements in the sequential patient heartrate data store used to generate the pattern of patient heart rate mayalso optionally be configured to a value between 1 and 20 elements witha nominal value of 10. The number of the most recent data elements inthe sequential patient heart rate data store used to generate thepattern of patient heart rate may also optionally be configured to avalue between 1 and 10 elements with a nominal value of 5. The processormay also optionally modify the number of most recent data elements inthe sequential patient heart rate data store that is used to generatethe pattern of patient heart rate in response to values in the patternof patient heart rate. For example, if the pattern of heart ratecontains values that are erratic or otherwise not consistent between twoor more sequential values, the processor may increase the number of mostrecent data elements in the sequential heart rate data store that isused to generate the pattern of heart rate.

The processor may optionally store one or more values of the patientheart rate in long term storage, which is available to the processorfollowing subsequent cycling of power to the controller 100. Theprocessor may store values of the patient heart rate in long-termstorage, which are indicative of the heart rate of the patientcorresponding to specific patterns of wakefulness that are describedpreviously. The controller 100 may optionally modify the characteristicsof the repeating pattern of stimulation in response to the values in thepattern of patient heart rate and the values of the patient heart ratecorresponding to specific patterns of wakefulness in long-term storage.By way of example, if the most recent pattern of patient heart rateindicates the patient heart rate is decreasing and has an average valuelarger than the value of the patient heart rate corresponding to awakefulness state of asleep in long term storage, the controller 100 mayreduce the relative intensity of the stimulations of the repeatingpattern of stimulation. By way of another example, if the most recentpattern of patient heart rate indicates the patient heart rate isdecreasing and has an average value less than or equal to the value ofthe patient heart rate corresponding to a wakefulness state of asleep inlong term storage, the processor may terminate the repeating pattern ofstimulation.

It will be understood by one skilled in the art that the data used forcomparison with the most recent pattern of patient heart rate forpurposes of modifying the characteristics of the repeating pattern ofstimulation may derive from sources other than the patient. For example,rather than using values of the patient heart rate corresponding to aspecific state of wakefulness stored in long term storage, publisheddata for normal patient heart rate values corresponding to a specificstate of wakefulness may be used.

It will be understood by one skilled in the art that the generation ofthe previously described physiological data, including the sequentialpatient heart rate data store, and the pattern of patient heart rate,may optionally be performed by the processor in each of the patient wornmodules 310 in coordination with the processor in the controller 100.

FIG. 4 Description

FIG. 4 is a perspective view of a fourth embodiment of the presentinvention. In this embodiment a portable, battery powered controller 100as previously described in FIG. 1 is coupled to two portable, batterypowered, patient worn modules 302 and to one portable, battery powered,patient worn module 402.

The patient worn modules 302 are the same as described previously inFIG. 3.

The patient worn modules 402 each contain a processor (not visible),which is coupled to one or more wireless communication mechanisms (notvisible), and a stimulator (not visible). The stimulator may optionallycomprise multiple light emitting diodes (LEDs) arranged in a horizontalarray, which when energized create a visual stimulation when coupled toa patient.

The patient worn module 402, and the patient worn modules 302, may beoptionally attached to a single adjustable belt 404.

The controller 100 is optionally coupled to the two patient worn modules302 through the wireless communication mechanisms of each device, and,the controller 100 is optionally coupled to the patient worn module 402through the wireless communication mechanisms of each device.

The controller 100 controls the operation of the patient worn module 402to generate a repeating pattern of stimulation by energizing andde-energizing the LEDs sequentially from one end of the array to theother, pausing for a period of time and then energizing andde-energizing the LEDs sequentially in the reverse order, and thenpausing for a period of time before repeating the entire sequence. Therepeating pattern of stimulation is controlled as described previouslyin FIG. 1.

The controller 100 may automatically adjust the characteristics of therepeating pattern of stimulation in response to physiological datareceived from the patient worn modules 302 as described previously inFIG. 3. The controller 100 may optionally automatically adjust theduration of time for the LEDs to energize and de-energize sequentiallyfrom one end of the array to the other during each cycle of therepeating pattern of stimulation. The controller 100 may also optionallyautomatically adjust the duration of time to pause between energizingand de-energizing the LEDS from one end of the array to the other duringeach cycle of the repeating pattern of stimulation. The controller 100may also optionally automatically adjust the relative intensity of thebrightness produced by each LED during each cycle of the repeatingpattern of stimulation. The controller 100 may also optionallyautomatically terminate or initiate the repeating pattern ofstimulation.

Variable controls may be presented in the user interface on thecontroller 100, which control the initial characteristics of therepeating pattern of stimulation as described previously in FIG. 1.

Controls may also be presented in the user interface on the controller100 which allow the user to select a preconfigured initial set ofcharacteristics of the repeating pattern of stimulation as describedpreviously in FIG. 1.

In a typical context in which the controller 100 and patient worn module402, and, two patient worn modules 302 are used, a patient prepares forsleep and attaches the patient worn modules 302 and patient worn module402 to a single adjustable belt 404 and secures the adjustable beltaround the patient's head such that the patient worn modules 302 arepositioned to detect the electrical activity of the patient's brain, andthe patient worn module 402 is positioned such that the horizontal arrayof LEDs is over the patient's eyes and centered horizontally over thepatient's nose. The patient applies power to the patient worn modules402 and 302 by activating a power control (not visible). The patientapplies power to the controller 100 and the controller establisheswireless communication with each of the patient worn modules using thewireless communication mechanisms of each device. The patient adjuststhe previously mentioned controls on the controller 100 to set theinitial characteristics of the repeating pattern of stimulation, andinitiates the repeating pattern of stimulation as described previouslyin FIG. 1. The patient then attempts to initiate sleep. The controller100 will terminate the repeating pattern of stimulation after the periodof time set by the patient as described previously in FIG. 1.

Subsequent to the initiation of the repeating pattern of stimulation,the processor in each patient worn module 302 periodically processessignals received from the EEG sensors and generates the spectral powerdensity for multiple configurable frequency ranges as describedpreviously in FIG. 3, and transmits this data to the controller 100through the wireless communication mechanisms of each device. Theprocessor in the controller 100 processes this data and generates asequential relative spectral power data store, patterns of relativespectral power for the frequency ranges, and a sequential patientwakefulness data store as described previously in FIG. 3. Additionally,the processor in the controller 100 periodically processes thesequential relative spectral power data store and compares the values inthe patterns of relative spectral power for the frequency ranges, andmay optionally modify the characteristics of the repeating pattern ofstimulation in response to these values in the same manner as previouslydescribed in FIG. 3.

FIG. 5 Description

FIG. 5 is a perspective view of a fifth embodiment of the presentinvention.

In this embodiment a portable, battery powered controller 100 aspreviously described in FIG. 1 is coupled to two portable, batterypowered, patient worn modules 302, to two portable, battery powered,patient worn modules 502, and to one portable, battery powered, patientworn module 506.

The patient worn modules 302 are the same as described previously inFIG. 3.

The patient worn modules 502 each contain a processor (not visible),which is coupled to one or more wireless communication mechanisms (notvisible), and a stimulator (not visible). The stimulator may optionallycomprise one or more acoustic audio transducers, which when activatedcreate an audible stimulation when coupled to a patient.

The patient worn modules 502 and the patient worn modules 302 may beoptionally attached to a single adjustable belt 504.

The patient worn module 506 contains a processor (not visible), which iscoupled to one or more wireless communication mechanisms (not visible),and one or more physiological sensors (not visible). The physiologicalsensors may optionally comprise a body temperature sensor, whichmeasures the patient's body temperature when coupled to the patient. Theprocessor in the patient worn module 506 may periodically process datafrom the body temperature sensor and transmit the resulting data to thecontroller via the wireless communication mechanisms of each device. Thepatient worn module 506 may be optionally attached to an adjustable belt508.

The controller 100 is optionally coupled to the two patient worn modules302 through the wireless communication mechanisms of each device, and,the controller 100 is optionally coupled to the patient worn modules 502through the wireless communication mechanisms of each device, and thecontroller 100 is optionally coupled to the patient worn module 506through the wireless communication mechanisms of each device.

The controller 100 controls the operation of the patient worn modules502 to generate a repeating pattern of stimulation. The repeatingpattern of stimulation is as described previously in FIG. 1.

The controller 100 may automatically adjust the characteristics of therepeating pattern of stimulation in response to physiological datareceived from the patient worn modules 302 and 506. The controller 100may optionally automatically adjust the duration of time that eachstimulator is active during each cycle of the repeating pattern ofstimulation. The controller 100 may also optionally automatically adjustthe duration of time that neither stimulator is active during each cycleof the repeating pattern of stimulation. The controller 100 may alsooptionally automatically adjust the relative intensity of thestimulations produced by each stimulator during each cycle of therepeating pattern of stimulation. The controller 100 may also optionallyautomatically terminate or initiate the repeating pattern ofstimulation.

Variable controls may be presented in the user interface on thecontroller 100, which control the initial characteristics of therepeating pattern of stimulation as described previously in FIG. 1.

Controls may also be presented in the user interface on the controller100 which allow the user to select a preconfigured initial set ofcharacteristics of the repeating pattern of stimulation as describedpreviously in FIG. 1.

In a typical context in which the controller 100 and two patient wornmodules 502, and, two patient worn modules 302 and, one patient wornmodule 506 are used, a patient prepares for sleep and attaches thepatient worn modules 302 and patient worn modules 502 to a singleadjustable belt 504 and secures the belt around the patient's head suchthat the patient worn modules 302 are positioned to detect theelectrical activity of the patient's brain, and the patient worn modules502 are each positioned over one of the patient's ears. The patientattaches the patient worn modules 506 to an adjustable belt 508 andsecures the adjustable belt around the patient's wrist such that thepatient worn module 506 is positioned to detect the patient's bodytemperature. The patient applies power to each of the patient wornmodules 502, 302 and 506 by activating a control (not visible). Thepatient applies power to the controller 100 and the controllerestablishes wireless communication with each of the patient worn modulesusing the wireless communication mechanisms of each device. The patientadjusts the previously mentioned controls on the controller 100 to setthe initial characteristics of the repeating pattern of stimulation, andinitiates the repeating pattern of stimulation as described previouslyin FIG. 1. The patient then attempts to initiate sleep. The controller100 will terminate the repeating pattern of stimulation after the periodof time set by the patient as described previously in FIG. 1.

Subsequent to the initiation of the repeating pattern of stimulation,the processor in each patient worn module 302 periodically processessignals received from the EEG sensors and generates the spectral powerdensity for multiple configurable frequency ranges as describedpreviously in FIG. 3, and transmits this data to the controller 100through the wireless communication mechanisms of each device. Theprocessor in the controller 100 processes this data and generates asequential relative spectral power data store, patterns of relativespectral power for the frequency ranges, and a sequential patientwakefulness data store as described previously in FIG. 3. Additionally,the processor in the controller 100 periodically processes thesequential relative spectral power data store and compares the values inthe patterns of relative spectral power for the frequency ranges, andmay optionally modify the characteristics of the repeating pattern ofstimulation in response to these values in the same manner as previouslydescribed in FIG. 3.

Additionally, subsequent to the initiation of the repeating pattern ofstimulation, the processor in the patient worn module 506 periodicallyprocesses signals received from the body temperature sensor, andgenerates data indicative of the patient's body temperature, andtransmits this data to the controller 100 through the wirelesscommunication mechanism of each device.

Additionally, subsequent to the initiation of the repeating pattern ofstimulation, the processor in the controller 100 periodically processesthe data indicative of the patient's body temperature and stores thisdata in sequential order to create a sequential patient body temperaturedata store. The processor in the controller 100 periodically processesthe sequential patient body temperature data store and generates apattern of patient body temperature. The pattern of patient bodytemperature may consist of a configurable number of the most recent dataelements in the sequential patient body temperature data store. Thenumber of the most recent data elements in the sequential patient bodytemperature data store used to generate the pattern of patient bodytemperature may optionally be configured to a value between 1 and 30elements with a nominal value of 15. The number of the most recent dataelements in the sequential patient body temperature data store used togenerate the pattern of patient body temperature may also optionally beconfigured to a value between 1 and 20 elements with a nominal value of10. The number of the most recent data elements in the sequentialpatient body temperature data store used to generate the pattern ofpatient body temperature may also optionally be configured to a valuebetween 1 and 10 elements with a nominal value of 5. The processor mayalso optionally modify the number of most recent data elements in thesequential patient body temperature data store that is used to generatethe pattern of patient body temperature in response to values in thepattern of patient body temperature. For example, if the pattern of bodytemperature contains values that are erratic or otherwise not consistentbetween two or more sequential values, the processor may increase thenumber of most recent data elements in the sequential body temperaturedata store that is used to generate the pattern of body temperature.

The processor in the controller 100 may optionally store one or morevalues of the patient body temperature in long-term storage, which isavailable to the processor following subsequent cycling of power to thecontroller 100. The processor may store values of the patient bodytemperature in long-term storage, which are indicative of the patient'sbody temperature corresponding to specific patterns of wakefulness thatare described previously. The processor in the controller 100 mayoptionally modify the characteristics of the repeating pattern ofstimulation in response to the values in the pattern of patient bodytemperature and the values of the patient body temperature in long-termstorage. By way of example, if the most recent pattern of patient bodytemperature indicates the patient body temperature is decreasing and hasan average value larger than the value of the patient body temperaturecorresponding to a wakefulness state of asleep in long term storage, thecontroller 100 may reduce the relative intensity of the stimulations ofthe repeating pattern of stimulation. By way of another example, if themost recent pattern of patient body temperature indicates the patientbody temperature is decreasing and has an average value smaller than thevalue of the patient body temperature corresponding to a wakefulnessstate of asleep in long term storage, the controller 100 may terminatethe repeating pattern of stimulation.

It will be understood by one skilled in the art that the data used forcomparison with the most recent pattern of patient body temperature forpurposes of modifying the characteristics of the repeating pattern ofstimulation may derive from sources other than the patient. For example,rather than using values of the patient body temperature correspondingto a specific state of wakefulness stored in long term storage,published data for normal patient body temperature values correspondingto a specific state of wakefulness may be used.

Alternatively, the patient worn module 506 may optionally comprise ablood pressure sensor, which measures the patient's blood pressure whencoupled to the patient. The processor in the patient worn device 506 andthe processor in the controller 100 both process data derived from theblood pressure sensor in the same manner as described for the bodytemperature sensor. The controller 100 may optionally modify thecharacteristics of the repeating pattern of stimulation in response tothis data in the same manner as described for the body temperaturesensor.

FIG. 6 Description

FIG. 6 is a block diagram of the controller 100 of FIG. 1. The blockdiagram shows the touch-sensitive screen 104 and the wirelesscommunication mechanisms 608 described previously and other devices thatare not visible in FIG. 1 such as the processor 600, volatile memory602, non-volatile memory 604, and wired communication mechanisms 610.

The controller 100 may include one or more types of memory. For example,a non-volatile memory 604, such as a flash memory, may be used to storeinstructions for the processor while the controller 100 is powered down.When the controller 100 is powered on, these instructions may be copiedto a faster, volatile memory 602, such as synchronous dynamic randomaccess memory (SDRAM) by a basic input/output system (BIOS) or the like.Once the volatile memory 602 is loaded with instructions, the processor600 executes the instructions stored in the volatile memory 602. Theseinstructions control the operation of the processor 600; that is, theprocessor 600 is programmed by these instructions to perform theoperations described herein.

The non-volatile memory 604 may also store data while the controller 100is powered down, so if the battery becomes exhausted, this data will beavailable after the battery is recharged or replaced. The processor 600may optionally store configuration settings for the controls thatdetermine the characteristics of the repeating pattern of stimulation inthe non-volatile memory 604. The processor 600 may also optionally storedata in the non-volatile memory 604, which are indicative of therespiration rate of the patient corresponding to specific patterns ofwakefulness as described in FIG. 2. The processor 600 may alsooptionally store data in the non-volatile memory 604, which areindicative of the heart rate of the patient corresponding to specificpatterns of wakefulness as described in FIG. 3. The processor 600 mayalso optionally store data in the non-volatile memory 604, which areindicative of the spectral power density data of the patientcorresponding to specific patterns of wakefulness as described in FIG.3. The processor 600 may also optionally store data in the non-volatilememory 604, which are indicative of the body temperature of the patientcorresponding to specific patterns of wakefulness as described in FIG.5. The processor 600 may also optionally store data in the non-volatilememory 604, which are indicative of the blood pressure of the patientcorresponding to specific patterns of wakefulness as described in FIG.5.

The controller 100 may include one or more wired communicationmechanisms 610, which may be coupled to a wired communication port 106.The wired communication port 106 may be coupled to external computersystems using suitable wired communication devices. The processor 600may communicate with external computer systems and may exchange datawith those systems. The processor 600 may optionally transmit datastored in non-volatile memory 604, or volatile memory 602 to externalcomputer systems for purposes of analysis. The processor 600 may alsooptionally receive data from external computer systems and store thisdata in non-volatile memory 604 or volatile memory 602. For example,said data may be used to change the default configurationcharacteristics of the repeating pattern of stimulation. The processor600 may also optionally receive instructions from external computersystems that it stores in non-volatile memory 604 which may be used tocontrol the operation of the processor 600 as described previously.

Although not shown in FIG. 6, the controller 100 may include a bus tointerconnect the processor 600 and the touch-sensitive screen 104, thewireless communication mechanisms 608, the non-volatile memory 604 thevolatile memory 602, and the wired communication mechanisms 610. Thecontroller 100 may also include other circuits (not shown) toautomatically connect the battery, processor 600 and other components.

FIG. 7 Description

FIG. 7 is a block diagram of the patient worn modules describedpreviously. The block diagram shows the wireless communicationmechanisms 708, the stimulation mechanisms 712 and the physiologicalsensor mechanisms 714 described previously and other devices that arenot visible in the previous figures such as the processor 700, volatilememory 702, non-volatile memory 704, and wired communication mechanisms710.

The patient worn module may include one or more types of memory. Forexample, a non-volatile memory 704, such as a flash memory, may be usedto store instructions for the processor while the patient worn module ispowered down. When the patient worn module is powered on, theseinstructions may be copied to a faster, volatile memory 702, such assynchronous dynamic random access memory (SDRAM) by a basic input/outputsystem (BIOS) or the like. Once the volatile memory 702 is loaded withinstructions, the processor 700 executes the instructions stored in thevolatile memory 702. These instructions control the operation of theprocessor 700; that is, the processor 700 is programmed by theseinstructions to perform the operations described herein.

The non-volatile memory 704 may also store data while the patient wornmodule is powered down, so if the battery becomes exhausted, this datawill be available after the battery is recharged or replaced. Theprocessor 700 may optionally store configuration settings for thecontrols that determine the characteristics of the repeating pattern ofstimulation in the non-volatile memory 704.

The patient worn modules may include one or more wired communicationmechanisms 710, which may be coupled to a wired communication port 706.The wired communication port 706 may be coupled to external computersystems using suitable wired communication devices. The processor 700may communicate with external computer systems and may exchange datawith those systems. The processor 700 may optionally transmit datastored in non-volatile memory 704, or volatile memory 702 to externalcomputer systems for purposes of analysis. The processor 700 may alsooptionally receive data from external computer systems and store thisdata in non-volatile memory 704 or volatile memory 702. For example,said data may be used to change the default configurationcharacteristics of the repeating pattern of stimulation. The processor700 may also optionally receive instructions from external computersystems that it stores in non-volatile memory 704 which may be used tocontrol the operation of the processor 700 as described previously.

Although not shown in FIG. 7, the patient worn modules may include a busto interconnect the processor 700 and the wireless communicationmechanisms 708, the non-volatile memory 704, the volatile memory 702,the wired communication mechanisms 710, the stimulation mechanisms 712and the physiological sensor mechanisms 714. The patient worn modules110 may also include other circuits (not shown) to automatically connectthe battery, processor 700 and other components.

The patient worn modules may include zero or more stimulation mechanisms712, which may be coupled to the processor 700 and which respond toinstructions received from the processor 700 to create control signalsthat determine the activation characteristics of the stimulatorspreviously described, which provide the previously described repeatingpattern of stimulation. The stimulation mechanisms 712 may comprisesuitable electronic devices that provide stimulations when coupled to apatient. The stimulation mechanism may optionally comprise a vibrationmotor, which may include an eccentric mass counter weight attached tothe shaft of a motor, which when activated, causes a tactile stimulationwhen coupled to a patient. The stimulation mechanism may also optionallycomprise a vibration motor, which may include a mass attached to theshaft of a linear motor, which when activated, causes a tactilestimulation when coupled to a patient. The stimulation mechanism mayalso optionally comprise a piezoelectric vibration motor, which whenactivated, causes a tactile stimulation when coupled to a patient. Thestimulation mechanism may also optionally comprise an electroactivepolymer, which responds to an induced electrical current by contracting,causing a tactile stimulation when coupled to a patient. The stimulationmechanism may also optionally comprise transcutaneous electrical nervestimulators (TENS), which stimulate nerves through the induction of anelectrical current when coupled to a patient. The stimulation mechanismmay also optionally comprise multiple light emitting diodes (LEDs) that,when activated cause a visual stimulation when coupled to a patient. Thestimulation mechanism may also optionally comprise multiple acousticaudio transducers that, when activated cause an audible stimulation whencoupled to a patient. The stimulation mechanism may also optionallycomprise any combination of vibration motor, electroactive polymer,TENS, LEDs, acoustic audio transducers, or other suitable devices.

The patient worn modules may include zero or more physiological sensormechanisms 714, which may be coupled to the processor 700 and whichtransmit data to the processor indicative of the physiological state ofa patient. The processor 700 may optionally process this physiologicaldata and consequently modify the characteristics of the repeatingpattern of stimulation as described previously. The processor 700 mayoptionally transmit the physiological data to the controller 100 asdescribed previously. The physiological sensor mechanism may optionallycomprise one or more actimetry sensors, which detect gross motormovement when coupled to a patient. The physiological sensor mechanismmay also optionally comprise one or more Electroencephalography (EEG)sensors, which detect electrical activity of the brain when coupled to apatient. The physiological sensor mechanism may also optionally compriseone or more respiratory sensors, which detect the respiration rate whencoupled to a patient. The physiological sensor mechanism may alsooptionally comprise one or more heart rate sensors, which detect theheart rate when coupled to a patient. The physiological sensor mechanismmay also optionally comprise one or more body temperature sensors, whichdetect body temperature when coupled to a patient. The physiologicalsensor mechanism may also optionally comprise one or more blood pressuresensors, which detect blood pressure when coupled to a patient. Thephysiological sensor mechanisms may also optionally comprise anycombination of actimetry sensors, EEG sensors, respiratory sensors,heart rate sensors, body temperature sensors, blood pressure sensors orother physiological sensor.

FIG. 8 Description

FIG. 8 is a flowchart that illustrates operation of one embodiment ofthe present invention. At 800 execution of the previously describedrepeating pattern of stimulation is initiated according to preconfiguredparameters which determine the characteristics of the repeating patternof stimulation, and control passes to decision block 802. At 802 thepreconfigured parameter, which determines the total time for executionof the controller 100 per sleep session, is compared to the elapsed timeof execution of the controller 100 since the initiation of the firstrepeating pattern of stimulation of the current sleep session. If theelapsed time of execution since the initiation of the first repeatingpattern of stimulation of the current sleep session exceeds thepreconfigured parameter which determines the total time for execution ofthe controller 100 per sleep session, control is passed to 804,otherwise control passes to decision block 807. At 804 the repeatingpattern of stimulation is terminated and all operations are stopped.

At decision block 807 the preconfigured parameter, which determines thetotal time for execution of any single repeating pattern of stimulation,is compared to the elapsed time of execution of the currently executingrepeating pattern of stimulation. If the elapsed time of execution ofthe currently executing repeating pattern of stimulation exceeds thepreconfigured parameter which determines the total time for execution ofany single repeating pattern of stimulation, control is passed to 818,otherwise control passes to 808.

At 808 physiological data are acquired from one or more patient wornmodules and are processed to generate data indicative of the patient'scurrent pattern of wakefulness, and sequential physiological data, whichare optionally stored in the Sleep History data store 810 as describedpreviously in FIGS. 1, 2, 3, 4, 5, and 6, and control is passed todecision block 812.

At decision block 812 data from the Sleep History data store 810 areprocessed to determine if the patient is experiencing a transition tosleep as described previously in FIGS. 1, 2, 3, 4, 5, and 6. If such atransition is occurring, control passes to block 814, otherwise controlpasses to decision block 817. At 814 the parameters of the repeatingpattern of stimulation are optionally modified as described previously,and control passes to decision block 817.

At decision block 817 data from the Sleep History data store 810 areprocessed to determine if the patient has achieved a sleep state. If asleep state has been achieved, control passes to block 818, otherwise itpasses to block 802 and execution continues as described above.

At 818 execution of the repeating pattern of stimulation is terminatedand control passes to block 820.

FIG. 9 Description

FIG. 9 is a continuation of the flowchart in FIG. 8. Control passes fromblock 820 to decision block 900. At 900 the preconfigured parameter,which determines the total time for execution of the controller 100 persleep session, is compared to the elapsed time of execution of thecontroller 100 since the initiation of the first repeating pattern ofstimulation of the current sleep session. If the elapsed time ofexecution since the initiation of the first repeating pattern ofstimulation of the current sleep session exceeds the preconfiguredparameter which determines the total time for execution of thecontroller 100 per sleep session, all operations are stopped. Otherwisecontrols passes to block 902.

At 902 physiological data are acquired from one or more patient wornmodules and are processed to generate data indicative of the patient'scurrent pattern of wakefulness, and sequential physiological data, whichare optionally stored in the Sleep History data store 810 as describedpreviously in FIGS. 1, 2, 3, 4, 5, and 6, and control is passed todecision block 904.

At decision block 904 data from the Sleep History data store 810 areprocessed to determine if the patient is experiencing a transition towakefulness from sleep as described previously in FIGS. 1, 2, 3, 4, 5,and 6. If such a transition is occurring, control passes to block 822,otherwise control passes to decision block 900 and operations continueas described above.

At block 822, control passes to block 800 and the repeating pattern ofstimulation is re-initiated as described in FIG. 8.

A medical device for initiating and/or accelerating onset of sleep andmaintaining the sleep state after sleep onset, through delivery ofalternate bilateral stimulation to a patient in response tophysiological characteristics of the patient has been described asincluding processors controlled by instructions stored in a memory. Thememory may be random access memory (RAM), read-only memory (ROM), flashmemory or any other memory, or combination thereof, suitable for storingcontrol software or other instructions and data. Some of the functionsperformed by the medical device have been described with reference toflowcharts and/or block diagrams. Those skilled in the art shouldreadily appreciate that functions, operations, decisions, etc. of all ora portion of each block, or a combination of blocks, of the flowchartsor block diagrams may be implemented as computer program instructions,software, hardware, firmware or combinations thereof. Those skilled inthe art should also readily appreciate that instructions or programsdefining the functions of the present invention may be delivered to aprocessor in many forms, including, but not limited to, informationpermanently stored on non-writable storage media (e.g. read-only memorydevices within a computer, such as ROM, or devices readable by acomputer I/O attachment, such as CD-ROM or DVD disks), informationalterably stored on writable storage media (e.g. floppy disks, removableflash memory and hard drives) or information conveyed to a computerthrough communication media, including wired or wireless computernetworks. In addition, while the invention may be embodied in software,the functions necessary to implement the invention may optionally oralternatively be embodied in part or in whole using firmware and/orhardware components, such as combinatorial logic, Application SpecificIntegrated Circuits (ASICs), Field-Programmable Gate Arrays (FPGAs) orother hardware or some combination of hardware, software and/or firmwarecomponents.

While the invention is described through the above-described exemplaryembodiments, it will be understood by those of ordinary skill in the artthat modifications to, and variations of, the illustrated embodimentsmay be made without departing from the inventive concepts disclosedherein. For example, although some aspects of the medical device havebeen described with reference to a flowchart, those skilled in the artshould readily appreciate that functions, operations, decisions, etc. ofall or a portion of each block, or a combination of blocks, of theflowchart may be combined, separated into separate operations orperformed in other orders. Furthermore, disclosed aspects, or portionsof these aspects, may be combined in ways not listed above. Accordingly,the invention should not be viewed as being limited to the disclosedembodiments.

By way of example, and for illustrative purposes, components of themedical device described herein may include one or more of thefollowing:

In one embodiment of this device, the patient worn modules could beimplemented with the Sony Ericsson SmartWatch, and the controller couldbe implemented with the Sony Ericsson Xperia mini pro smart phone.

The SmartWatch incorporates a vibration motor capable of providingtactile stimulation, an accelerometer capable of determining gross bodymovements, a Blue Tooth communication mechanism, memory and a processor,which is coupled to the vibration motor, the accelerometer, the memoryand the Blue Tooth communication mechanism. The processor in theSmartWatch can be independently programmed using the Android open sourcesoftware platform to control the operation of the vibration motor,interpret signals from the accelerometer and to communicate with otherdevices using Blue Tooth.

The Xperia mini pro incorporates a touch sensitive screen, a Blue Toothcommunication mechanism, memory and a processor, which is coupled to thetouch sensitive screen, the Blue Tooth communication mechanism and thememory. The processor in the Xperia mini pro can be independentlyprogrammed using the Android open source software platform tocommunicate with the SmartWatch to receive physiological data and totransmit signals that control the SmartWatch. The processor can beprogrammed to respond to the physiological data by transmitting controlsignals to the SmartWatch that modify the operation of the vibrationmotor. The processor in the Xperia mini pro can also be programmed toprovide user accessible controls on the touch sensitive screen, and tointerpret the values of these controls to control the operation of theSmartWatch.

The patient worn modules could also be constructed from commerciallyavailable components. For example, microcontrollers incorporatingprocessors and memory are available from a number of vendors, includingthe AVR family from Atmel Corporation, and the ProgrammableSystem-on-Chip family from Cypress Semiconductor. Multiple wirelesscommunication mechanisms are available that support the Blue Tooth andZigbee wireless communication standards, such as the AtherosRadio-On-Chip for Mobile family of products from Qualcomm, and theBluetooth 4.0 Low Energy Modules from Panasonic.

A person of ordinary skill in the art would also recognize that thepatient worn modules could be constructed from commercially availablephysiological sensors including:

the wireless headband and EEG sensor from Zeo,

the WakeMate actimetry wristband from WakeMate,

the MEMS series of accelerometers from Analog Devices,

the H7 heart rate sensor from Polar,

the Acoustic Respiratory sensor from Masimo,

the AD592 integrated circuit temperature transducer from Analog Devices.

A patient may optionally use the device before attempting to initiatesleep by turning on the controller and turning on two patient wornmodules, which each contain a stimulator comprising a vibration motorconstructed of a small electrical motor with an eccentric mass counterweight mounted to its shaft, and, a physiological sensor comprising anactimetry sensor constructed of a three-axis accelerometer. The patientthen connects the two patient worn modules to the controller through awireless communication mechanism and attaches the patient worn modulesto individual adjustable belts and secures one belt around each of thepatient's wrists. The patient adjusts the user accessible controls onthe controller to:

set the desired initial characteristics of the repeating pattern ofstimulation,

detect when the patient is transitioning to a sleep state and toconsequently reduce the intensity of the stimulations,

detect when the patient is in a stable sleep state and to consequentlyterminate the stimulations,

detect when the patient is being aroused from sleep after initial onsetof sleep, and to consequently resume the repeating pattern ofstimulation,

set a length of time after which the controller will terminate thestimulations,

and, set a length of time after which the controller will stopattempting to initiate or maintain the sleep state of the patient.

A patient may also optionally use the device before attempting toinitiate sleep by turning on the controller, turning on two patient wornmodules, which each contain a stimulator comprising a vibration motorconstructed of a small linear electrical motor with a mass mounted toits shaft, and turning on a third patient worn module which contains aphysiological sensor comprising a blood pressure sensor. The patientthen connects the three modules to the controller through a wirelesscommunication mechanism and attaches the two modules containingstimulators to individual adjustable belts and secures one belt aroundeach of the patient's wrists, and attaching the third module containinga blood pressure sensor to a separate belt and secures the belt aroundthe patient's arm such that it will detect the patient's blood pressure.The patient adjusts the user accessible controls on the controller to:

set the desired initial characteristics of the repeating pattern ofstimulation,

detect when the patient is transitioning to a sleep state and toconsequently reduce the intensity of the stimulations,

detect when the patient is in a stable sleep state and to consequentlyterminate the stimulations,

detect when the patient is being aroused from sleep after initial onsetof sleep, and to consequently resume the repeating pattern ofstimulation,

set a length of time after which the controller will terminate thestimulations,

and, set a length of time after which the controller will stopattempting to initiate or maintain the sleep state of the patient.

A patient may also optionally use the device before attempting toinitiate sleep by turning on the controller, turning on two patient wornmodules, which each contain a stimulator comprising transcutaneouselectrical nerve stimulators (TENS), and turning on a third patient wornmodule which contains a physiological sensor comprising a bodytemperature sensor. The patient then connects the three modules to thecontroller through a wireless communication mechanism and attaches thetwo modules containing stimulators to individual adjustable belts andsecures one belt around each of the patient's wrists, and attaching thethird module containing the body temperature sensor to a separate beltand secures the belt around the patient's arm such that it will detectthe patient's body temperature. The patient adjusts the user accessiblecontrols on the controller to:

set the desired initial characteristics of the repeating pattern ofstimulation,

detect when the patient is transitioning to a sleep state and toconsequently reduce the intensity of the stimulations,

detect when the patient is in a stable sleep state and to consequentlyterminate the stimulations,

detect when the patient is being aroused from sleep after initial onsetof sleep, and to consequently resume the repeating pattern ofstimulation,

set a length of time after which the controller will terminate thestimulations,

and, set a length of time after which the controller will stopattempting to initiate or maintain the sleep state of the patient.

A patient may also optionally use the device before attempting toinitiate sleep by turning on the controller, turning on one patient wornmodule, which contains a stimulator comprising multiple light emittingdiodes (LEDs) arranged in a horizontal array and turns on two additionalpatient worn modules, which each contain a physiological sensorcomprising an Electroencephalography (EEG) sensor. The LEDs are arrangedin a horizontal array such that when activated, the LEDs will generate arepeating pattern of stimulation by energizing and de-energizing theLEDs sequentially from one end of the array to the other, pausing for aperiod of time and then energizing and de-energizing the LEDssequentially in the reverse order, and then pausing for a period of timebefore repeating the entire sequence. The patient connects the threemodules to the controller through a wireless communication mechanism andattaches the three modules to a single adjustable belt, securing saidbelt around the patient's head such that the modules containing the LEDsare positioned over the patient's eyes and centered horizontally overthe patient's nose and the modules containing the EEG sensors arepositioned to detect the electrical activity of the patient's brain. Thepatient adjusts the user accessible controls on the controller to:

set the desired initial characteristics of the repeating pattern ofstimulation,

detect when the patient is transitioning to a sleep state and toconsequently reduce the intensity of the stimulations,

detect when the patient is in a stable sleep state and to consequentlyterminate the stimulations,

detect when the patient is being aroused from sleep after initial onsetof sleep, and to consequently resume the repeating pattern ofstimulation,

set a length of time after which the controller will terminate thestimulations,

and, set a length of time after which the controller will stopattempting to initiate or maintain the sleep state of the patient.

A patient may also optionally use the device before attempting toinitiate sleep by turning on the controller, turning on two patient wornmodules, which each contain a stimulator comprising an acoustic audiotransducer and turning on two additional patient worn modules, whicheach contain a physiological sensor comprising an Electroencephalography(EEG) sensor. The patient connects the four modules to the controllerthrough a wireless communication mechanism and attaches the four modulesto a single adjustable belt, secures the belt around the patient's headsuch that one module containing an acoustic audio transducer ispositioned over each of the patient's ears, and the two modulescontaining the EEG sensors are positioned to detect the electricalactivity of the patient's brain. The patient adjusts the user accessiblecontrols on the controller to:

set the desired initial characteristics of the repeating pattern ofstimulation,

detect when the patient is transitioning to a sleep state and toconsequently reduce the intensity of the stimulations,

detect when the patient is in a stable sleep state and to consequentlyterminate the stimulations,

detect when the patient is being aroused from sleep after initial onsetof sleep, and to consequently resume the repeating pattern ofstimulation,

set a length of time after which the controller will terminate thestimulations,

and, set a length of time after which the controller will stopattempting to initiate or maintain the sleep state of the patient.

A patient may also optionally use the device before attempting toinitiate sleep by turning on the controller, turning on two patient wornmodules, which each contain a stimulator comprising an electroactivepolymer material and turning on a third patient worn module, whichcontains a physiological sensor comprising a respiratory sensor. Thepatient then connects the three modules to the controller through awireless communication mechanism and attaches the three modules to asingle adjustable belt and secures the belt around the patient's torsosuch that the two modules containing the stimulators are positioned onopposite lateral sides of the patient's body, and the third module ispositioned to detect the patient's respiration. The patient adjusts theuser accessible controls on the controller to:

set the desired initial characteristics of the repeating pattern ofstimulation,

synchronize the periodicity of the stimulations with the periodicity ofthe patient's respiration rate,

detect when the patient is transitioning to a sleep state and toconsequently reduce the intensity of the stimulations,

detect when the patient is in a stable sleep state and to consequentlyterminate the stimulations,

detect when the patient is being aroused from sleep after initial onsetof sleep, and to consequently resume the repeating pattern ofstimulation,

set a length of time after which the controller will terminate thestimulations,

and, set a length of time after which the controller will stopattempting to initiate or maintain the sleep state of the patient.

I claim:
 1. A device for initiating an onset of sleep comprising: afirst stimulation module configured to be positioned at a first locationon a patient's body; a second stimulation module configured to bepositioned at a second location on the patient's body; wherein each ofthe first and second stimulation modules outputs at least one of atactile, auditory, visual, neurological, and/or physiologicalstimulation when activated; one or more physiological sensors configuredto be coupled to the patient's body, wherein the one or morephysiological sensors are configured to receive physiological signalsindicating a state of wakefulness of the patient; and a controller incommunication with the one or more physiological sensors and the firstand second stimulation modules and configured to communicate a signal tothe first and second stimulation modules, the signal comprising apattern of alternate bilateral stimulation to activate the firststimulation module for a first time interval and the second stimulationmodule for a second time interval, wherein the controller is configuredto initiate the onset of sleep in the patient.
 2. The device of claim 1,wherein the alternate bilateral stimulation is separated by a third timeinterval when neither the first stimulation module nor the secondstimulation module is activated.
 3. The device of claim 2, wherein thecontroller controls a duration of the third time interval.
 4. The deviceof claim 3, wherein the duration of the third time interval is between10 milliseconds and 3000 milliseconds.
 5. The device of claim 3, whereinthe duration of the third time interval is between 100 milliseconds and2000 milliseconds.
 6. The device of claim 1, wherein the controllercontrols a stimulation intensity provided by the first stimulationmodule and a stimulation intensity provided by the second stimulationmodule in response to the signals indicating the state of wakefulness ofthe patient.
 7. The device of claim 1, wherein the controller controls aduration of the first time interval and a duration of the second timeinterval in response to the signals indicating the state of wakefulnessof the patient.
 8. The device of claim 7, wherein the duration of thefirst time interval is between 10 milliseconds and 3000 milliseconds andthe duration of the second time interval is between 10 milliseconds and3000 milliseconds.
 9. The device of claim 7, wherein the duration ofeach of the first time interval and the second time interval is between500 milliseconds and 2000 milliseconds.
 10. The device of claim 7,wherein the duration of each of the first time interval and the secondtime interval is between 100 milliseconds and 500 milliseconds.
 11. Thedevice of claim 7, wherein the duration of each of the first timeinterval and the second time interval is between 10 milliseconds and 100milliseconds.
 12. The device of claim 1, wherein the one or morephysiological sensors comprises any of an actimetry sensor, arespiratory sensor, a heart rate sensor, an EEG sensor, a bodytemperature sensor, or a blood pressure sensor.
 13. The device of claim1, wherein the first and second stimulation modules comprises any of atranscutaneous electrical nerve stimulator, an auditory stimulator or avibratory stimulator.
 14. The device of claim 1, wherein the controlleris in wireless communication with the first stimulation module, thesecond stimulation module, the one or more physiological sensors, or acombination thereof.
 15. The device of claim 1, wherein the first andsecond stimulation modules are configured for placement on a wrist, anarm, or a leg of the patient.
 16. The device of claim 1, wherein the oneor more physiological sensors configured to be coupled to the patient'sbody comprises any of an actimetry sensor, a respiratory sensor, a heartrate sensor, an electroencephalography sensor, a body temperaturesensor, or a blood pressure sensor.
 17. The device of claim 16, whereinthe one or more physiological sensors are configured to be coupled tothe patient's body comprises one or more actimetry sensors and whereineach of the first stimulation module and second stimulation moduleprocesses relative position data from the one or more actimetry sensors.18. The device of claim 17, wherein a time between generation ofrelative position data from the one or more actimetry sensors is in arange of about 1 second to about 120 seconds.
 19. The device of claim17, wherein relative position data comprises a number of gross motormovements experienced by the patient in a range of about 1 second toabout 360 seconds.
 20. A method comprising steps of: positioning a firststimulation module on a patient's body in a first location; positioninga second stimulation module on the patient's body in a second location,wherein the first and second stimulation modules output at least one ofa tactile, auditory, visual, neurological, and/or physiologicalstimulation; delivering bilateral stimulation through the first andsecond stimulation modules, wherein the step of delivering comprises:applying alternate stimulation to two bilateral positions of a patient'sbody according to a temporal pattern such that the positions arestimulated in different time intervals; monitoring at least onephysiological parameter of the patient, wherein the least onephysiological parameter indicates a state of wakefulness of the patient;and controlling the application of the alternate stimulation to the twobilateral positions of the patient's body in response to the least onemonitored physiological parameter so as to initiate onset of sleep inthe patient.
 21. The method of claim 20, further comprising maintaininga sleep state after the onset of sleep.
 22. The method of claim 20,wherein a duration of each of the different time intervals is between 10milliseconds and 3000 milliseconds.
 23. The method of claim 20, whereinthe alternate bilateral stimulation is separated by a period of timewhen neither the first stimulation module nor the second stimulationmodule is activated.
 24. The method of claim 23, wherein the duration ofthe period of time when neither the first stimulation module nor thesecond stimulation module is activated is between 10 milliseconds and3000 milliseconds.
 25. The method of claim 20, further comprisingrepeating the alternate stimulation to the two bilateral positions ofthe patient's body.
 26. The method of claim 20, further comprisingmeasuring the patient's state of wakefulness, and automaticallymodifying the alternate bilateral stimulation in response to a change ofthe patient's measured state of wakefulness.
 27. The method of claim 20,wherein the step of positioning the first stimulation module on thepatient's body in the first location comprises a step of placing thefirst stimulation module on a first wrist of the patient and wherein thestep of positioning the second stimulation module on the patient's bodyin the second location comprises a step of placing the secondstimulation module on a second wrist of the patient.
 28. The method ofclaim 20, wherein monitoring at least one physiological parametercomprises using a physiological sensor.
 29. The method of claim 28,wherein the physiological sensor comprises any of an actimetry sensor, arespiratory sensor, a heart rate sensor, an EEG sensor, a bodytemperature sensor, or a blood pressure sensor.